MAUDE Adverse Event Report: ARTHREX, INC. CURVED SPEAR, FIBERTAK, REUSABLE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CURVED SPEAR, FIBERTAK, REUSABLE
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a shoulder instability surgery the curved guide for the fibertak became obstructed with the implant inside, which had fractured.Despite multiple attempts, including high-pressure irrigation, lubricant, and other agents, it could not be removed.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: CURVED SPEAR, FIBERTAK, REUSABLE
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 25021481
• Report Number: 1220246-2026-02534
• Device Sequence Number: 10450792
• Product Code: LXH
• UDI-Device Identifier: 00888867354265
• UDI-Public: (01)00888867354265(11)230501(10)0072313
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CURVED SPEAR, FIBERTAK, REUSABLE
• Device Catalogue Number: AR-3610CTC
• Device Lot Number: 0072313
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown